FDA 510(k) Application Details - K973199

Device Classification Name Catheters, Suction, Tracheobronchial

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510(K) Number K973199
Device Name Catheters, Suction, Tracheobronchial
Applicant AMSINO INTL., INC.
833 TOWNE CENTER DR.
POMONA, CA 91767 US
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Contact RICHARD Y LI
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Regulation Number 868.6810

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Classification Product Code BSY
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Date Received 08/26/1997
Decision Date 09/10/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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